Question 1

Which type of inspection generally performed when regulatory authorities perceive a public threat, detect or suspect any fraudulent activity, counterfeit products?

Options :

A : Pre-market product approval

B : Internal audit

C : Routine regulatory inspection

D : For-cause inspection

Answer: D

Question 2

Which of the following is to identify high-risk manufacturing or product-usage steps that could lead to potential harms?

Options :

A : Control chart

B : Scatter diagram

C : Brainstorming

D : Flowchart

Answer: D

Question 3

According to QSIT (Quality System Inspection Technique), ‘medical device reporting’ is a satellite subsystem of which subsystem?

Options :

A : Corrective and preventive action

B : Production and process controls

C : Material controls

D : Management controls

Answer: A

Question 4

Which of the following are the two primary documents governing medical device softwares?

Options :

A : ISO 11607-1

B : ISO 10993-1

C : ANSI/AAMI/IEC 62304:2006 and FDA guidance General Principles of Software Validation

D : AAMI TIR22

Answer: C

Question 5

Which of the following audits are generally more in depth than the other audits?

Options :

A : Regulatory inspection

B : 3rd party audit

C : 1st party audit

D : 2nd party audit

Answer: C